FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework

September 18, 2017

On 07 September, 2017, FDA announced its plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework.

FDA’s goal is to ensure that its policies and regulations keep pace with the challenges encountered in protecting consumers, and the opportunities to improve lives.

This new effort includes areas where FDA’s rules concerning new drugs are being used in ways that may create obstacles to the timely entry of generic competition. FDA stated that they wants to make sure their policies aren’t being misused in ways that thwart the competition that Congress intended when it created the modern generic drug framework. FDA reported that they are aware that vigorous generic competition can help benefit patients by lowering drug costs, which improves access to medicines. This is one example where FDA indicated that a closer analysis of their existing policies can help make sure FDA regulations are having their intended purpose.

FDA is also exploring ways to modernize regulations in a manner that will benefit all Americans. To achieve this, FDA is not only looking at what new regulations or policies they require in order to be most effective in fulfilling their public health responsibilities. FDA is also taking a closer look to see if they need to revise, update, and in some cases eliminate existing regulations to help them better keep pace with scientific advancement and the people that they serve. FDA stated that they need policies that are as modern as the products that they are being asked to evaluate, and a regulatory framework that uses efficient tools to achieve their vital consumer protection role.

FDA indicated that they need to take a risk-based approach in everything they do in order to make sure they are using their resources efficiently. FDA’s goal is to have regulations that reflect modern risks and opportunities, and use the full scope of FDA authorities to achieve their consumer protection mission. Per FDA, this approach also aligns their efforts with the Administration-wide goal for federal regulatory reform to improve how government serves the American people.

Consequently, FDA is asking themselves and others to think about how current regulations could be reshaped to achieve their public health objectives through more efficient approaches. FDA is opening a number of public dockets to solicit feedback from patients, consumers, health providers, caregivers, industry, health groups, academia, as well as state, local and tribal governments, and public health partners.